This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to
adult patients with histologically confirmed GBM and/or other glioma subtypes with
FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.
Patients will be enrolled in two groups. Group 1 will enroll patients who are not candidates
for surgery. Group 2 will enroll patients who are surgical candidates. Patients from both
groups will be evaluated for tumor response and progression by MRI every 8 weeks until
disease progression or discontinuation from study using RANO criteria.
1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time
of diagnosis or prior relapse.
2. Written documentation of local or central laboratory determination of amplification
or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in
FGFR1, FGFR2,or FGFR3
3. RANO defined tumor progression by MRI in comparison to a prior scan
4. Patients must have received prior external beam radiotherapy and temozolomide.
1. History of another primary malignancy
2. Prior or current treatment with a FGFR inhibitor
3. Neurological symptoms related to underlying disease requiring increasing doses of
4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If
previously on an EIAED, the patient must be off of it for at least two weeks prior to
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both